MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On 21aug2017 our affiliate in (b)(4) received an email from an eye care provider (ecp) who diagnosed a patient (pt) with a corneal ulcer while wearing the 1 day acuvue trueye brand contact lenses.A call was placed to the ecp who reported he/she wanted to change the pts power from -4.00 to -4.25.No additional medical information was provided in the call.On 21aug2017 a call was placed to the pt and additional information was provided: pt reported he/she felt a discomfort while wearing the suspect lens initially.The pt reported visits to the ecp on (b)(6) 2017, but pt could not provide the event date.The pt reported he/she was diagnosed with a corneal ulcer in the right eye; pt reports the ecp advised the pt ¿it was a side effect of wearing contact lenses¿.The pt was prescribed 3 eye drops; opieye vigamox: to use every 2 hours, ocuflox to use before bed; pt reported he/she does not wear lenses every day.Pt reported the suspect contact lens was discarded.On 31aug2017 an email was received from the pt with the medical report.Additional medical information was provided as follows: ¿marginal cornea ulcer on (b)(6) 2017; idiopathic corneal ulcer on (b)(6) 2017 ¿ pt went to 2 different hospitals.Prescription: optima drop (eye inflammation) every 2 hrs; ocuflox oint (eye inflammation) to right eye before bedtime; mungmun ocufloxacin tb (microbial infection); dexifen tb (antipyretic-analgesic); vegamox 0.5 drops (eye inflammation) every 2 hours; hyaluronic drops (dryeye) frequently; verase tb (antiinflamm-antiphlogistic); recostar tb (for peptic ulcer)¿.On 05sep2017 an email was sent to the affiliate for clarification of the 2 corneal ulcer diagnoses received: marginal cornea ulcer on (b)(6) 2017; idiopathic corneal ulcer on (b)(6) 2017.Per the affiliate, the pt reported the first treating ecp advised him/her to see a specialist.On 13sep2017 a call was placed to the pt to see if the corneal ulcer event had resolved, but no further information was received.The date of event is reported as (b)(6) 2017.No additional medical information has been received.A lot history review was performed for lot 5440740107: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 5440740107 was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On file review, it was noted that the (b)(6) 2017 follow-up phone call information from the pt was mistakenly omitted from the initial submission: pt reported that (b)(6) 2017 was the last visit to the ecp and pt will send the medical report; pt reported that the eye seemed to be fine; pt reported the ecp advised the pt that the corneal ulcer is healed, but the pt should not return to lens wear for about 2 months; pt reported he/she is still using the eye drops prescribed with same dosage.On (b)(6) 2017 a follow-up call was placed to the pt to check the condition of the right eye.The pt provide the additional information as follows: the pt reported he/she will be going to the eye care provider (ecp) again next week.Pt reports the treatment frequency has not changed and pt is still using the eye drops as previously reported.The pt has not yet returned to contact lens wear.The pt is currently wearing glasses.On (b)(6) 2017 a follow-up phone call was placed to the pt for additional medical information, but no additional information was received.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6866328
• MDR Text Key: 86260246
• Report Number: 9617710-2017-05042
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 1D4
• Device Lot Number: 5440740107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention